Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-06

Study Completion Date

2019-02-06

Brief Summary

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This clinical trial studies movement tracking devices in optimizing and monitoring physical activity in patients with solid tumors undergoing chemotherapy in a health care facility during the day without spending the night. Movement tracking devices, such as Microsoft Kinect 2 and Microsoft Band 2, may help doctors learn about the health of cancer patients.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To determine the feasibility of monitoring cancer patients using wrist-worn activity monitors and movement trackers.

SECONDARY OBJECTIVES:

I. To evaluate the association between activity and patient reported fatigue. II. To evaluate the association between movement and incidents of health care interventions (hospitalizations, physical visits, intravenous hydration, etc.)

TERTIARY OBJECTIVES:

I. To compare physician and patient assessed Eastern Cooperative Oncology Group (ECOG) and Karnofsky performance status scores with the data obtained from movement trackers.

OUTLINE:

Patients perform 2 physical activities in an exam room that are recorded using a Microsoft Kinect 2 stationary movement tracking device on days 1 and 21. The first activity is rising from a chair, walking 10 feet, and returning to the chair. The second activity is moving from the chair to the step-up examination table. Patients also wear a movement tracking wristband, Microsoft Band 2, around their wrist, complete a smartphone application based patient reported outcome (PRO) questionnaire, and weigh themselves daily for 60 days.

After completion of study, patients are followed up at 90 days.

Conditions

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Solid Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Observational (physical activity, PROs)

Patients perform 2 physical activities in an exam room that are recorded using a Microsoft Kinect 2 stationary movement tracking device on days 1 and 21. The first activity is rising from a chair, walking 10 feet, and returning to the chair. The second activity is moving from the chair to the step-up examination table. Patients also wear a movement tracking wristband, Microsoft Band 2, around their wrist, complete a smartphone application based PRO questionnaire, and weigh themselves daily for 60 days.

Group Type EXPERIMENTAL

Accelerometer

Intervention Type OTHER

Wear Microsoft Band 2

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Physical Activity Measurement

Intervention Type OTHER

Perform physical activities recorded by Microsoft Kinect 2

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Complete PRO questionnaires

Interventions

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Accelerometer

Wear Microsoft Band 2

Intervention Type OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Physical Activity Measurement

Perform physical activities recorded by Microsoft Kinect 2

Intervention Type OTHER

Telephone-Based Intervention

Complete PRO questionnaires

Intervention Type BEHAVIORAL

Other Intervention Names

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ACTIVITY

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of a solid tumor, undergoing palliative or adjuvant therapy
* Undergoing at least 2 planned cycles of highly emetogenic chemotherapy defined according to the Hekseth scale; the cycles may range in duration from 14 days to 28 days, according to standard of care practices
* Ability to understand and the willingness to sign a written informed consent
* Willingness to wear sensors to track physical activity, Global Positioning System (GPS) location, and provide symptom ratings each night for up to 60 days
* Able to read English, Spanish, or Traditional Mandarin to complete patient reported outcomes
* Able to ambulate without an assistive device
* Able to operate a smartphone and wearable wristband

Exclusion Criteria

* Patients may not be missing limbs
* Patient does not have a diagnosis of a hematologic malignancy
* Patients with symptomatic brain metastases are excluded from this clinical trial; those with asymptomatic brain metastasis are permitted; it is permissible to have the patient on corticosteroids to eliminate symptoms of brain metastasis
* Patient with a known movement disorder such as Parkinson's disease, choreoathetoid movement disorders, essential tremor if that movement disorder is of sufficient severity to require drug therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No